Federal agencies issue guidance to explain and interpret the application of statutes and regulations to particular compliance situations. The degree to which guidance is binding depends on the type of guidance and the agency involved. For example, the FDA states that its guidance documents represent the agency’s current thinking on a topic, do not create or confer any rights, and do not bind the FDA or the public. The FDA stresses that alternative approaches are allowed if they satisfy the requirements of applicable statutes and regulations.

Additionally, a court attempting to interpret a statute or regulation may take guidance into consideration and defer to the interpretation provided by the government agency that has the authority to interpret the provision.

When dealing with administrative agency guidance, you should bear in mind that the guidance is based on the statutes or regulations in effect at the time the guidance was issued. Often, statutory or regulatory changes or court decisions alter the applicable requirements, and as a result administrative guidance may no longer be valid. Also, although an agency may issue guidance interpreting how a statute or regulation applies to a particular situation, a court interpreting the requirement may arrive at a different interpretation. Courts often defer to agency interpretations, but they do not always do so.

Industry Guidelines

Non-FDA Guidance

International Guidance

Prescription Drugs

FDA Guidance

510(k) Guidance